Ratchford John N, Brock-Simmons Regina, Augsburger Amanda, Steele Sonya U, Mohn Kristie, Rhone Mandi, Bo Jinyan, Costello Kathleen
Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Int J MS Care. 2014 Summer;16(2):92-8. doi: 10.7224/1537-2073.2013-017.
This study was undertaken to determine how frequently patients receiving natalizumab for multiple sclerosis (MS) experience recrudescence of their MS symptoms at the end of the dosing cycle.
One hundred consecutive MS patients receiving natalizumab completed a survey evaluating changes in symptoms during the natalizumab dosing cycle. Ninety-one patients also completed questionnaires at two time points: the first week after natalizumab infusion and the last week of the dosing cycle. These included the Multiple Sclerosis Quality of Life-54 (MSQOL-54), Fatigue Visual Analog Scale (VAS), Fatigue Severity Scale (FSS), and Beck Depression Inventory-II (BDI-II).
End of dosing interval (EDI) symptoms were reported as currently being experienced by 57% of respondents. An additional 10% reported that they previously experienced that phenomenon, but not currently, and 33% reported never experiencing this. In those with EDI symptoms, they began to occur a median of 21 days after infusion and improved again a median of 1 day after infusion. The most common symptoms reported were fatigue, weakness, walking impairment, and cognitive difficulties. No specific demographic or disease characteristics were associated with this phenomenon. In the subgroup with EDI symptoms, the MSQOL-54, Fatigue VAS, FSS, and BDI-II scores were all significantly worse in the last week of the dosing cycle when compared with the first week. No difference was seen in these scores between first and last week in the subgroup not experiencing symptom recrudescence.
Recrudescence of fatigue, weakness, walking impairment, or cognitive difficulties at the end of the dosing cycle occurs in about two-thirds of MS patients receiving natalizumab.
本研究旨在确定接受那他珠单抗治疗多发性硬化症(MS)的患者在给药周期结束时MS症状复发的频率。
100例连续接受那他珠单抗治疗的MS患者完成了一项评估那他珠单抗给药周期内症状变化的调查。91例患者还在两个时间点完成了问卷调查:那他珠单抗输注后的第一周和给药周期的最后一周。这些问卷包括多发性硬化症生活质量-54量表(MSQOL-54)、疲劳视觉模拟量表(VAS)、疲劳严重程度量表(FSS)和贝克抑郁量表第二版(BDI-II)。
57%的受访者报告目前正在经历给药间隔期末(EDI)症状。另外10%的受访者报告他们之前经历过这种现象,但目前没有,33%的受访者报告从未经历过。在有EDI症状的患者中,症状开始出现的中位时间为输注后21天,再次改善的中位时间为输注后1天。报告的最常见症状是疲劳、虚弱、行走障碍和认知困难。没有特定的人口统计学或疾病特征与这种现象相关。在有EDI症状的亚组中,与第一周相比,给药周期最后一周的MSQOL-54、疲劳VAS、FSS和BDI-II评分均显著更差。在未经历症状复发的亚组中,第一周和最后一周的这些评分没有差异。
接受那他珠单抗治疗的MS患者中,约三分之二在给药周期结束时出现疲劳、虚弱、行走障碍或认知困难的复发。